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BackgroundThe World Health Organization estimates that 56 million women and girls live with female genital schistosomiasis (FGS) in sub-Saharan Africa. FGS is often confused with symptoms of other genital abnormalities, and gold standard diagnosis with colposcopy is infeasible in most health facilities. Schistosomiasis haematobium is endemic in Zambia, yet routine screening or diagnostic efforts for FGS remain unavailable. Our study aimed to develop and pilot test a feasible FGS screening algorithm to implement in Zambian government clinics.Methodology/Principal FindingsWe recruited 499 women from a longitudinal cohort of HIV-negative adult women in Lusaka and Ndola, Zambia. We used demographic, risk factor, and symptom data collected from standardized surveys, gynecological exams, and laboratory tests to develop a screening algorithm for FGS among a derivation cohort (n=349). After cross-validation using 5-fold iterative resampling, the algorithm was applied in a holdout sample of the cohort (n=150). The prevalence of FGS (ascertained by expert review) was 23.4% in the study population. The screening algorithm included childhood and travel exposure to rivers and streams; testing positive for visual inspection of the cervix with acetic acid; hematuria; reporting less than the median average age at sexual debut (

Abstract Background Risks to mother and fetus following Ebola virus infection are very high. Evaluation of safety and immunogenicity of non-replicating Ebola vaccine candidates is a priority for use in pregnant women. This is the protocol for a randomized, open-label, single-center phase 3 clinical trial of the safety, reactogenicity, and immunogenicity of the 2-dose Ebola vaccine regimen in healthy adult pregnant women. This 2-dose regimen has been shown to be safe, judged effective, and approved in non-pregnant populations. Methods A total of 2000 adult (≥ 18 years of age) pregnant women will be enrolled from antenatal care facilities in Western Rwanda and randomized (1:1) to receive the 2-dose Ebola vaccine regimen (Ad26.ZEBOV, MVA-BN-Filo (group A)) or control (unvaccinated pregnant women (group B)). The primary objectives are to (1) assess adverse maternal/fetal outcomes in randomized pregnant women up to 1.5 months after delivery and (2) assess adverse neonatal/infant outcomes in neonates/infants born to randomized women up to 3.5 months after birth. The frequency and relatedness of all serious adverse events in women and newborns from randomization or birth, respectively, until study end will be reported. The reactogenicity and unsolicited adverse events of the 2-dose Ebola vaccine regimen in all vaccinated pregnant women (group A) will be reported. We will also assess the immunogenicity of the 2-dose Ebola vaccine regimen in 150 pregnant women who are anticipated to receive both vaccine doses within the course of their pregnancy (a subset of the 1000 pregnant vaccinated women from group A) compared to 150 non-pregnant women vaccinated after delivery (a subset of group B). The persistence of maternal antibodies in 75 infants born to women from the group A subset will be assessed. Exploratory analyses include assessment of acceptability of the 2-dose Ebola vaccine regimen among group A and assessment of maternal antibodies in breast milk in 50 women from group A and 10 controls (women from group B prior to vaccination). Discussion This study is intended to support a label variation to relax restrictions on use in pregnant women, a vulnerable population with high medical need. Trial registration Clinicaltrials.gov NCT04556526 . September 21, 2020.

Abstract Background Though the Rwandan Ministry of Health (MOH) prioritizes the scale-up of postpartum family planning (PPFP) programs, uptake and sustainability of PPFP services in Rwanda are low. Furthermore, highly effective long-acting reversible contraceptive method use (LARC), key in effective PPFP programs, is specifically low in Rwanda. We previously pilot tested a supply-demand intervention which significantly increased the use of postpartum LARC (PPLARC) in Rwandan government clinics. In this protocol, we use an implementation science framework to test whether our intervention is adaptable to large-scale implementation, cost-effective, and sustainable. Methods In a type 2 effectiveness-implementation hybrid study, we will evaluate the impact of our PPFP intervention on postpartum LARC (PPLARC) uptake in a clinic-randomized trial in 12 high-volume health facilities in Kigali, Rwanda. We will evaluate this hybrid study using the RE-AIM framework. The independent effectiveness of each PPFP demand creation strategy on PPLARC uptake among antenatal clinic attendees who later deliver in a study facility will be estimated. To assess sustainability, we will assess the intervention adoption, implementation, and maintenance. Finally, we will evaluate intervention cost-effectiveness and develop a national costed implementation plan. Discussion Adaptability and sustainability within government facilities are critical aspects of our proposal, and the MOH and other local stakeholders will be engaged from the outset. We expect to deliver PPFP counseling to over 21,000 women/couples during the project period. We hypothesize that the intervention will significantly increase the number of stakeholders engaged, PPFP providers and promoters trained, couples/clients receiving information about PPFP, and PPLARC uptake comparing intervention versus standard of care. We expect PPFP client satisfaction will be high. Finally, we also hypothesize that the intervention will be cost-saving relative to the standard of care. This intervention could dramatically reduce unintended pregnancy and abortion, as well as improve maternal and newborn health. Our PPFP implementation model is designed to be replicable and expandable to other countries in the region which similarly have a high unmet need for PPFP. Trial registration ClinicalTrials.gov NCT05056545 . Registered on 31 March 2022.

Abstract Background There is unmet need for family planning in Rwanda. We previously developed an evidence-based couples’ family planning counseling (C)FPC program in the capital city that combines: (1) fertility goal-based family planning counseling with a focus on long-acting reversible contraceptive (LARC) for couples wishing to delay pregnancy; (2) health center capacity building for provision of LARC methods, and (3) LARC promotion by community health workers (CHW) trained in community-based provision of oral and injectable contraception. From 2015 to 2016, this service was integrated into eight government health centers in Kigali, reaching 6072 clients and resulting in 5743 LARC insertions. Methods From May to July 2016, we conducted cross-sectional health center needs assessments in 30 rural health centers using surveys, key informant interviews, logbook extraction, and structured observations. The assessment focused on the infrastructure, materials, and human resources needed for LARC demand creation and provision. Results Few nurses had received training in LARC insertion [41% implant, 27% intrauterine device (IUD)]. All health centers reported working with CHW, but none trained in LARC promotion. Health centers had limited numbers of IUDs (median 10), implants (median 39), functional gynecological exam tables (median 2), and lamps for viewing the cervix (median 0). Many did not have backup power supplies (40%). Most health centers reported no funding partners for family planning assistance (60%). Per national guidelines, couples’ voluntary HIV counseling and testing (CVCT) was provided at the first antenatal visit at all clinics, reaching over 80% of pregnant women and their partners. However, only 10% of health centers had integrated family planning and HIV services. Conclusions To successfully implement (C)FPC and LARC services in rural health centers across Rwanda, material and human resource capacity for LARC provision will need to be greatly strengthened through equipment (gynecological exam tables, sterilization capacity, lamps, and backup power supplies), provider trainings and follow-up supervision, and new funding partnerships. Simultaneously, awareness of LARC methods will need to be increased among couples through education and promotion to ensure that demand and supply scale up together. The potential for integrating (C)FPC with ongoing CVCT in antenatal clinics is unique in Africa and should be pursued.

Measles is a vaccine-preventable viral disease whose vaccination coverage remains low in Zambia, where the target group for vaccination is children aged 9 to 18 months. In addition to inadequate measles vaccination coverage among children, few studies address potential resultant immunity gaps among adults. We analyzed data from a simulated HIV vaccine efficacy trial (SiVET) conducted from 2015–2017 among adult Zambian women of childbearing age to determine measles antibody seroprevalence before and after vaccination with the measles, mumps and rubella (MMR) vaccine. We used MMR vaccine as a substitute for an experimental HIV vaccine as part of a simulation exercise to prepare for an HIV vaccine efficacy trial. We found that 75% of women had measles antibodies prior to receiving MMR, which increased to 98% after vaccination. In contrast, mumps and rubella antibody prevalence was high before (93% and 97%, respectively) and after (99% and 100%, respectively) vaccination. The low baseline measles seropositivity suggests an immunity gap among women of childbearing age. We recommend that measles vaccination programs target women of childbearing age, who can pass antibodies on to neonates. Moreover, administering the MMR vaccine to clinical trial candidates could prevent measles, mumps or rubella-related adverse events during actual trials.

Abstract Severe sepsis is a time critical condition which is known to have a high mortality rate. Evidence suggests that early diagnosis and early administration of antibiotics can reduce morbidity and mortality from sepsis. The prehospital phase of emergency medical care may provide the earliest opportunity for identification of sepsis and delivery of life-saving treatment for patients. We aimed to assess the feasibility of (1) paramedics recognising and screening patients for severe sepsis, collecting blood cultures and administering intravenous antibiotics; and (2) trial methods in order to decide whether a fully-powered trial should be undertaken to determine safety and effectiveness of this intervention. Paramedics were trained in using a sepsis screening tool, aseptic blood culture collection and administration of intravenous antibiotics. If sepsis was suspected, paramedics randomly allocated patients to intervention or usual care using scratchcards. Patients were followed up at 90 days using linked anonymised data to capture length of hospital admission and mortality. We collected self-reported health-related quality of life at 90 days. We pre-specified criteria for deciding whether to progress to a fully-powered trial based on: recruitment of paramedics and patients; delivery of the intervention; retrieval of outcome data; safety; acceptability; and success of anonymised follow-up. Seventy-four of the 104 (71.2%) eligible paramedics agreed to take part and 54 completed their training (51.9%). Of 159 eligible patients, 146 (92%) were recognised as eligible by study paramedics, and 118 were randomised (74% of eligible patients, or 81% of those recognised as eligible). Four patients subsequently dissented to be included in the trial (3%), leaving 114 patients recruited to follow-up. All recruited patients were matched to routine data outcomes in the Secure Anonymised Information Linkage Databank. Ninety of the 114 (79%) recruited patients had sepsis or a likely bacterial infection recorded in ED. There was no evidence of any difference between groups in patient satisfaction, and no adverse reactions reported. There were no statistically significant differences between intervention and control groups in Serious Adverse Events (ICU admissions; deaths). This feasibility study met its pre-determined progression criteria; an application will therefore be prepared and submitted for funding for a fully-powered multi-centre randomised trial. Trial registration: ISRCTN36856873 sought 16th May 2017; https://doi.org/10.1186/ISRCTN36856873

HIV-1 accessory proteins Nef and Vpu enhance viral pathogenesis through partially overlapping immune evasion activities. Attenuated Nef or Vpu functions have been reported in individuals who display slower disease progression, but few studies have assessed the relative impact of these proteins in non-B HIV-1 subtypes or examined paired proteins from the same individuals. Here, we examined the sequence and function of matched Nef and Vpu clones isolated from 29 long-term survivors (LTS) from Rwanda living with HIV-1 subtype A and compared our results to those of 104 Nef and 62 Vpu clones isolated from individuals living with chronic untreated HIV-1 subtype A from the same geographic area. Nef and vpu coding regions were amplified from plasma HIV RNA and cloned. The function of one intact, phylogenetically-validated Nef and Vpu clone per individual was then quantified by flow cytometry following transient expression in an immortalized CD4+ T-cell line. We measured the ability of each Nef clone to downregulate CD4 and HLA class I, and of each Vpu clone to downregulate CD4 and Tetherin, from the cell surface. Results were normalized to reference clones (Nef-SF2 and Vpu-NL4.3). We observed that Nef-mediated CD4 and HLA downregulation functions were lower in LTS compared to the control cohort (Mann-Whitney p=0.03 and p

Background: Ayres Sensory Integration (ASI) is widely employed by occupational therapists working with clients who experience challenges in sensory integration, including those with autism spectrum disorder (ASD). However, there is a dearth of research examining the feasibility of ASI outside of Western nations. This study documented the barriers associated with ASI in Saudi Arabia and assessed whether the intervention could improve process and participation skills. Methods: Single-Subject experimental design was used. The participant was a 4-year-old girl with ASD from Saudi Arabia. Data were gathered on sensory processing, motor skills, and participation in activities of daily living. The study used semi-structured interviews and assessments (Sensory Integration and Praxis Tests, the Sensory Processing Measure-Preschool, and the Peabody Developmental Motor Scale-2) to develop goals, identify outcome measures, and plan an ASI intervention. Results: Despite the limited availability of resources (e.g., toys, treatment spaces) and Arabic measures, improvements were observed on motor and sensory tasks and in occupational performance. Conclusion: ASI that adheres to the ASI fidelity tool can be of value for Saudi Arabian children with ASD. Additionally, the study provides a stepping-stone to further research for occupational therapists in Saudi Arabia working with children with ASD.

Abstract Background Algorithms that bridge the gap between syndromic sexually transmitted infection (STI) management and treatment based in realistic diagnostic options and local epidemiology are urgently needed across Africa. Our objective was to develop and validate a risk algorithm for Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) diagnosis among symptomatic Rwandan women and to compare risk algorithm performance to the current Rwandan National Criteria for NG/CT diagnosis. Methods The risk algorithm was derived in a cohort (n = 468) comprised of symptomatic women in Kigali who sought free screening and treatment for sexually transmitted infections and vaginal dysbioses at our research site. We used logistic regression to derive a risk algorithm for prediction of NG/CT infection. Ten-fold cross-validation internally validated the risk algorithm. We applied the risk algorithm to an external validation cohort also comprised of symptomatic Rwandan women (n = 305). Measures of calibration, discrimination, and screening performance of our risk algorithm compared to the current Rwandan National Criteria are presented. Results The prevalence of NG/CT in the derivation cohort was 34.6%. The risk algorithm included: age = 5, the risk algorithm had a sensitivity of 81%, specificity of 54%, positive predictive value (PPV) of 48%, and negative predictive value (NPV) of 85%. Internal and external validation showed similar predictive ability of the risk algorithm, which outperformed the Rwandan National Criteria. Applying the Rwandan National Criteria cutoff of > = 2 (the current cutoff) to our derivation cohort had a sensitivity of 26%, specificity of 89%, PPV of 55%, and NPV of 69%. Conclusions These data support use of a locally relevant, evidence-based risk algorithm to significantly reduce the number of untreated NG/CT cases in symptomatic Rwandan women. The risk algorithm could be a cost-effective way to target treatment to those at highest NG/CT risk. The algorithm could also aid in sexually transmitted infection risk and prevention communication between providers and clients.

Abstract Background When integrated with couples’ voluntary HIV counselling and testing (CVCT), family planning including long acting reversible contraceptives (LARC) addresses prongs one and two of prevention of mother-to-child transmission (PMTCT). Methods In this observational study, we enrolled equal numbers of HIV concordant and discordant couples in four rural and four urban clinics, with two Catholic and two non-Catholic clinics in each area. Eligible couples were fertile, not already using a LARC method, and wished to limit or delay fertility for at least 2 years. We provided CVCT and fertility goal-based family planning counselling with the offer of LARC and conducted multivariate analysis of clinic, couple, and individual predictors of LARC uptake. Results Of 1290 couples enrolled, 960 (74%) selected LARC: Jadelle 5-year implant (37%), Implanon 3-year implant (26%), or copper intrauterine device (IUD) (11%). Uptake was higher in non-Catholic clinics (85% vs. 63% in Catholic clinics, p

IntroductionRwanda has high unmet need for family planning (FP), especially in the postpartum period when women are advised to space pregnancies at least two years for improved maternal-child health. Despite interest in the copper intrauterine device (IUD), a highly cost-effective method, access and uptake remain low. This study aimed to determine factors associated with postpartum IUD (PPIUD) uptake after postpartum family planning (PPFP) counseling as well as provider perceptions of facilitators and barriers to clients' PPIUD uptake.MethodsPostpartum women who received PPFP counseling and were less than 6 weeks postpartum were recruited for a case-control study in Kigali, Rwanda in 2018. We recruited n = 74 women who had accepted and n = 91 women who had declined the PPIUD. Multivariate logistic regression analyses evaluated associations between women's socio-demographics, FP knowledge and decision-making, and the outcome of PPIUD uptake. Six focus groups (FGs) were conducted with FP providers (n = 24) and community health workers (n = 17) trained to deliver PPFP counseling to assess perceptions of PPFP counseling and facilitators and barriers to PPIUD uptake. FG discussions were recorded, translated, and analyzed for themes.ResultsFactors associated (PConclusionsKnowledge of the IUD and its benefits was associated with PPIUD uptake. There is need to refine PPFP counseling messages to address remaining knowledge gaps and concerns. Additionally, male partner involvement in FP counseling and decisions with their partners could be a key strategy to increase both PPIUD and FP uptake in Rwanda.

Background: Heterosexual couples contribute to most new HIV infections in areas of generalized HIV epidemics in sub-Saharan Africa. After Couples’ Voluntary HIV Counseling and Testing (CVCT), heterosexual concordant HIV negative couples (CNC) in cohabiting unions contribute to approximately 47% of residual new infections in couples. These infections are attributed to concurrent sexual partners, a key driver of the HIV epidemic in Zambia. Methods/design: Ten Zambian government clinics in two of the largest cities were randomized in matched pairs to a Strengthening Our Vows (SOV) intervention or a Good Health Package (GHP) comparison arm. SOV addressed preventing HIV infection from concurrent partners and protecting spouses after exposures outside the relationship. GHP focused on handwashing; water chlorination; household deworming; and screening for hypertension, diabetes and schistosomiasis. CNC were referred from CVCT services in government clinics. Follow-up includes post-intervention questionnaires and outcome assessments through 60 months. Longitudinal outcomes of interest include self-report and laboratory markers of condomless sex with outside partners and reported sexual agreements. We present baseline characteristics and factors associated with study arm and reported risk using descriptive statistics. Results: The mean age of men was 32 and 26 for women. On average, couples cohabited for 6 years and had 2 children. Baseline analyses demonstrated some failures of randomization by study arm which will be considered in future primary analyses of longitudinal data. An HIV/STI risk factor composite was not different in the two study arms. Almost one-quarter of couples had an HIV risk factor at baseline. Discussion: In preparation for future biomedical and behavioral interventions in sub-Saharan Africa, it is critical to understand and decrease HIV risk within CNC.

Most studies of HIV-1 transmission have focused on subtypes B and C. In this study, we determined the genomic sequences of the transmitted founder (TF) viruses from acutely infected individuals enrolled between 2005 and 2011 into IAVI protocol C in Rwanda and have compared these isolates to viruses from more recent (2016–2019) acute/early infections in three at risk populations – MSM, high risk women (HRW), and discordant couples (DC). For the Protocol C samples, we utilized near full-length single genome (NFLG) amplification to generate 288 HIV-1 amplicons from 26 acutely infected seroconverters (SC), while for the 21 recent seroconverter samples (13 from HRW, two from DC, and six from MSM), we PCR amplified overlapping half-genomes. Using PacBio SMRT technology combined with the MDPseq workflow, we performed multiplex sequencing to obtain high accuracy sequences for each amplicon. Phylogenetic analyses indicated that the majority of recent transmitted viruses from DC and HRW clustered within those of the earlier Protocol C cohort. However, five of six sequences from the MSM cohort branched together and were greater than 97% identical. Recombination analyses revealed a high frequency (6/26; 23%) of unique inter-subtype recombination in Protocol C with 19% AC and 4% CD recombinant viruses, which contrasted with only 6.5% of recombinants defined by sequencing of the pol gene previously. The frequency of recombinants was significantly higher (12/21; 57%) in the more recent isolates, although, the five related viruses from the MSM cohort had identical recombination break points. While major drug resistance mutations were absent from Protocol C viruses, 4/21 of recent isolates exhibited transmitted nevirapine resistance. These results demonstrate the ongoing evolution and increased prevalence of recombinant and drug resistant transmitted viruses in Rwanda and highlight the importance of defining NFLG sequences to fully understand the nature of TF viruses and in particular the prevalence of unique recombinant forms (URFs) in transmission cohorts.

Abstract Background We coordinated community health worker (CHW) promotions with training and support of government clinic nurses to increase uptake of long-acting reversible contraception (LARC), specifically the copper intrauterine device (IUD) and the hormonal implant, in Kigali, Rwanda. Methods From August 2015 to September 2016, CHW provided fertility goal-based family planning counseling focused on LARC methods, engaged couples in family planning counseling, and provided written referrals to clients expressing interest in LARC methods. Simultaneously, we provided didactic and practical training to clinic nurses on LARC insertion and removal. We evaluated: 1) aggregate pre- versus post-implementation LARC uptake as a function of CHW promotions, and 2) demographic factors associated with LARC uptake among women responding to CHW referrals. Results 7712 referrals were delivered by 184 CHW affiliated with eight government clinics resulting in 6072 family planning clinic visits (79% referral uptake). 95% of clinic visits resulted in LARC uptake (16% copper IUD, 79% hormonal implant). The monthly average for IUD insertions doubled from 29 prior to service implementation to 61 after (p

IntroductionThe longstanding inadequacies of syndromic management for genital ulceration and inflammation are well-described. The Rwanda National Guidelines for sexually transmitted infection (STI) syndromic management are not yet informed by the local prevalence and correlates of STI etiologies, a component World Health Organization guidelines stress as critical to optimize locally relevant algorithms.MethodsRadio announcements and pharmacists recruited symptomatic patients to seek free STI services in Kigali. Clients who sought services were asked to refer sexual partners and symptomatic friends. Demographic, behavioral risk factor, medical history, and symptom data were collected. Genital exams were performed by trained research nurses and physicians. We conducted phlebotomy for rapid HIV and rapid plasma reagin (RPR) serologies and vaginal pool swab for microscopy of wet preparation to diagnose Trichomonas vaginalis (TV), bacterial vaginosis (BV), and vaginal Candida albicans (VCA). GeneXpert testing for Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) were conducted. Here we assess factors associated with diagnosis of NG and CT in men and women. We also explore factors associated with TV, BV and VCA in women. Finally, we describe genital ulcer and RPR results by HIV status, gender, and circumcision in men.ResultsAmong 974 men (with 1013 visits), 20% were positive for CT and 74% were positive for NG. Among 569 women (with 579 visits), 17% were positive for CT and 27% were positive for NG. In multivariate analyses, factors associated with CT in men included younger age, responding to radio advertisements, 1 partner was associated with BV; being single and RPR+ was associated with TV; and having < = 1 partner in the last month, being pregnant, genital itching, discharge, and being HIV and RPR negative were associated with VCA. Genital ulcers and positive RPR were associated with being HIV+ and lack of circumcision among men. HIV+ women were more likely to be RPR+. In HIV+ men and women, ulcers were more likely to be herpetic rather than syphilitic compared with their HIV- counterparts.ConclusionsSyndromic management guidelines in Rwanda can be improved with consideration of the prevalence of confirmed infections from this study of symptomatic men and women representative of those who would seek care at government health centers. Inclusion of demographic and risk factor measures shown to be predictive of STI and non-STI dysbioses may also increase diagnostic accuracy.

Aim. To review current evidence regarding the effectiveness of occupational therapy coaching interventions for parents of children with sensory integration difficulties, delivered to individuals or groups of parents. Method. A historical scoping review was completed of empirical research records to summarize what is known and how this information can guide future research. The process was guided by PRISMA guidelines. Inclusion criteria were English language and peer-reviewed empirical studies of parent coaching intervention for children with sensory processing or sensory integration difficulties. Five databases were searched. Papers were critically reviewed using McMaster’s guidelines. Results. Four studies met the search criteria. Three studies took a direct coaching approach with individual parents or families. The fourth study took a mixed educational/coaching approach with groups of parents and teachers. Conclusion. There is some evidence to conclude that occupational therapists can deliver individual parent-focused coaching interventions which impact positively on individual child goals, parental stress, and sense of competence. Group intervention can lead to caregivers’ improved perceived and actual knowledge of sensory integration, as well as a sense of self-efficacy in dealing with sensory-related child behaviors. Current evidence is limited. Suggestions for future research are offered.

During the latest years, human infertility worsened all over the world and is nowadays reputed as a global public health issue. As a consequence, the adoption of Assisted Reproductive Technologies (ARTs) such as In Vitro Fertilization (IVF) is undergoing an impressive increase. In this context, one of the most promising strategies is the innovative adoption of extra-physiological materials for advanced sperm preparation methods. Here, by using a murine model, the addition of Graphene Oxide (GO) at a specific concentration has demonstrated to increase the spermatozoa fertilizing ability in an IVF assay, finding that 0.5 μg/ml GO addition to sperm suspensions before IVF is able to increase both the number of fertilized oocytes and embryos created with a healthy offspring given by Embryo Transplantation (ET). In addition, GO treatment has been found more effective than that carried out with methyl-β-cyclodextrin, which represents the gold standard in promoting in vitro fertility of mice spermatozoa. Subsequent biochemical characterization of its interaction with male gametes has been additionally performed. As a result, it was found that GO exerts its positive effect by extracting cholesterol from membranes, without affecting the integrity of microdomains and thus preserving the sperm functions. In conclusion, GO improves IVF outcomes in vitro and in vivo, defining new perspectives for innovative strategies in the treatment of human infertility.

Introduction: In two high-volume government hospitals, their two affiliated health facilities, and two additional health facilities, we developed and implemented postpartum intrauterine device (PPIUD) and postpartum (PP) implant promotional counseling and service delivery procedures between May-July 2017 in Kigali, Rwanda. Between August 2017 and July 2018, 9,073 pregnant women received PPIUD/PP implant promotions who later delivered in one of our selected facilities. Of those, 2,633 had PPIUDs inserted, and 955 had PP implants inserted. The goal of the present analysis is to detail implementation expenditures and estimate incremental costs per insertion and couple years of protection (CYP) for PPIUD and PP implant users. Methods: We detail the incremental costs during the implementation from the health system perspective (including both the implementation costs and the cost of contraceptive methods) and use of standard methods to estimate the cost per insertion and CYP for PPIUD and PP implant users. In addition to the incremental costs of labor and supplies, the costs of promotional activities are included. Research costs for formative work were excluded. Results: A total of $74,147 USD was spent on the implementation between August 2017 and July 2018. The largest expense (34% of total expenses) went toward personnel, including doctoral-level, administrative, data management and nurse counseling staff. Training for PPIUD and implant providers and promoters comprised 8% of total expenses. Recruitment and reimbursements comprised 6% of expenses. Costs of implants to the government comprised 12% of the expenses, much higher than the cost of IUDs (1%). Costs per insertion were $25/PPIUDs and $77/PP implant. Costs per CYP were $6/PPIUDs and $21/PP implant. Conclusion: Understanding the cost per PPIUD/PP implant inserted and CYP can help to inform the cost of scaling up PPIUD/PP implant service implementation activities and resource allocation decision-making by the Rwandan Ministry of Health.

In this paper we explore whether countries led by women have fared better during the COVID-19 pandemic than those led by men. Media and public health officials have lauded the perceived gender-related influence on policies and strategies for reducing the deleterious effects of the pandemic. We examine this proposition by analyzing COVID-19-related deaths globally across countries led by men and women. While we find some limited support for lower reported fatality rates in countries led by women, they are not statistically significant. Country cultural values offer more substantive explanation for COVID-19 outcomes. We offer several potential explanations for the pervasive perception that countries led by women have fared better during the pandemic, including data selection bias and Western media bias that amplified the successes of women leaders in OECD countries.

Background: The desire to space or prevent future pregnancies is high among postpartum women in Rwanda. However, the use of long-acting reversible contraception (LARC), especially the highly effective and cost-effective copper intrauterine device (IUD), is very low, whereas the rates of unintended pregnancy are high. This study aims to identify factors associated with pregnant women’s and couple’s interest in receiving a postpartum intrauterine device (PPIUD) within 6 weeks after delivery. Methods: A total of 150 pregnant women or couples attending antenatal care (ANC) in Kigali, Rwanda participated in this cross-sectional study. After participating in a postpartum LARC counseling session, surveys assessed participants’ demographics, pregnancy experiences and desires, and PPIUD knowledge, attitudes, practices, and interest. Multivariable logistic regression was used to model factors associated PPIUD interest within 6 weeks postpartum. Results: Although only 3% of women had ever used an IUD previously, 124 (83%) women were interested in receiving a PPIUD after counseling. Self-reporting physical side effects (adjusted odds ratio [aOR], 0.21; 95% confidence interval [CI], 0.06-0.75) and infection (aOR, 0.19; 95% CI, 0.04-0.85) as disadvantages to the IUD were significantly associated with no interest in receiving a PPIUD. Interest did not differ by male involvement. Conclusion: Recommendations to increase PPIUD uptake include educating pregnant women and couples about the method during ANC and addressing client myths and misconceptions about the IUD. This strategy allows pregnant women and couples to make informed decisions about their future contraception use, reduce unmet need for family planning, and reduce unintended pregnancy.

Abstract Background Sepsis is a common condition which kills between 36,000 and 64,000 people every year in the UK. Early recognition and management of sepsis has been shown to reduce mortality and improve the health and well-being of people with sepsis. Paramedics frequently come into contact with patients with sepsis and are well placed to provide early diagnosis and treatment. We aim to determine the feasibility of undertaking a fully powered randomised controlled trial (RCT) to test the clinical and cost-effectiveness of paramedics obtaining blood cultures from and administering IV antibiotics to patients with sepsis, so we can make a decision about whether to proceed to a fully powered randomised controlled trial, which will answer questions regarding safety and effectiveness for patients and benefit to the National Health Service (NHS). Methods/design This is an individually randomised, two-arm feasibility study for a randomised controlled trial with a 1:1 ratio. Sixty paramedics will receive training to assist them to recognise sepsis using a screening tool, obtain blood cultures, and provide IV antibiotics. If sepsis is suspected, paramedics will randomly allocate patients to intervention or usual care using their next sequential individually issued scratch card. Patients will be followed up at 90 days using linked anonymised data to capture length of hospital admission and mortality. We will also collect self-reported health-related quality of life (using SF-12) at this time. We will interview ten patients by telephone and hold a focus group with paramedics, to find out what they think about the intervention. Discussion At the end of this study, we will make a recommendation about whether a full randomised controlled trial of paramedics obtaining blood cultures and administering IV antibiotics for sepsis is warranted, and if so, we will develop a proposal for research funding in order to take the work forward. Trial registration ISRCTN, ISRCTN36856873